Safety is paramount when it comes to the supply chain for pharmaceutical products. The warehouse is perhaps the most important element of the supply chain for the safety of pharmaceutical products. This article will discuss the logistics of pharmaceutical warehouses. It will also tell you what to look for in third-party logistics providers (3PL).
Information about Pharmaceutical Warehousing
The Food and Drug Administration and Drug Enforcement Administration (DEA) strictly regulate pharmaceuticals. Current Good Manufacturing Practices (CGMPs) are the FDA’s industry standards. Also known as “Good Manufacturing Practice” (GMP) standards, they are FDA’s regulatory standards. These standards apply to pharmaceutical warehouses, processes, and to the drugs themselves.
The following CGMPs are related to pharmaceutical warehousing:
- To prevent contamination, drugs must be kept safe and positioned so that they can be inspected and cleaned.
- Every lot of drug products should be identified by a unique (and traceable code) and must also be identified as to their status (approved, quarantined, or rejected).
- The distribution process must be described in writing. These procedures include recall procedures.
- Written procedures should describe the proper storage conditions for each drug.
- Climate-controlled and temperature-controlled warehouses
This is a major problem in pharmaceutical warehousing. Different drugs have different storage requirements. Each drug must be stored in accordance with the manufacturer’s requirements. This can involve temperature-controlled warehousing and/or climate-controlled warehousing space – both of which require state-of-the-art control and monitoring equipment to keep the space within specific environmental parameters.
- Temperature-controlled storage. A warehouse that has temperature-controlled space utilizes cooling (and/or heating) units to keep the temperature within a set range. The units are strategically placed so that the temperature remains within a set range. There are many factors that will influence the placement and quantity of cooling units. These include the season (i.e. more units might be required during the summer), the height of the ceiling, the density of insulation, and the materials used in warehouse construction.
- Climate-controlled storage While many people use this term interchangeably with temperature-controlled storage, there are key differences between the two. Climate-controlled storage regulates the humidity and temperature of the area. Commercial humidifiers/de-humidifiers are used along with other equipment to ensure that humidity stays within required ranges for products.
- Temperature mapping. The sensors are used to measure the temperature in various areas of the warehouse. Many 3PLs will conduct temperature mapping several times per year. Based on the results, they adjust heating or cooling equipment. If mapping shows an area that is too hot, cooling equipment can be placed in the correct place.
- Temperature monitoring Temperature mapping is a proactive way to ensure optimal temperature coverage. Temperature monitoring is the daily observation and management. Kanban 3PLs partner with external monitoring firms to monitor temperatures and notify key personnel immediately of any significant changes.
Items that have common characteristics important to the manufacturer (e.g., the same expiration date) are given a lot number by the manufacturer and/or by a 3PL’s warehouse management system (WMS) as they are received by the warehouse. This lot number allows 3PLs to quickly identify batches of items in the event of a recall. This allows the 3PLs to quickly identify batches of items in the event of a recall using inventory management protocols such as FIFO (first in, first out; oldest lots will be distributed) and FEFO (“first expired, first out); products closest to expiration dates will receive distribution first).
Cross Contact Prevention
Some pharmaceutical products can be sensitive and may not work well with other products. Exposure to other products can adversely affect the efficacy and effectiveness of certain pharmaceuticals. The prevention of cross contact (i.e., exposure of one product to another) is therefore paramount at pharmaceutical storage facilities such as 3PL warehouses.
Cross-contact-prevention measures include:
- Separation of materials The pharmaceutical warehouse must keep products separate from one another. This includes the movement of products within unauthorized areas. Kanban’s warehouses have a section where certain products cannot be loaded, stored, or transported by anyone other than authorized personnel.
- Education for associates. Warehouse workers must be able to identify potential allergens in the facility and cross-contact opportunities. They also need to be familiar with the policies and procedures of the facility.
- Designation of facility sections The warehouse must clearly identify areas containing sensitive items. Unauthorized equipment and personnel cannot be allowed to enter.
- Sanitation efforts. After handling any pharma product, associates must wash their hands with soapy water. Proper clothing should be worn and must be changed or washed as necessary. It is important to maintain and clean equipment and storage areas in accordance with regulatory and facility requirements.
- Designation of supplies Stretch-wrap, pallets, and other supplies can be designated to a product type. Their use is limited to that particular product type.
- Quarantine for rejected items To prevent them from being used, rejected pharmaceutical items should be properly identified and quarantined. Incorrect or incomplete packaging of any item should be grounds for removal from the product pool until it is repackaged or disposed of.
Mock Recalls and Recalls
Recalls are common and involve products that have been damaged, near expiration, recalled due to safety concerns or removed from circulation. The 3PL will be able to identify the location of each item and separate them using its WMS, as all products are scanned at the point of entry. The items are put on hold while further instructions are made. The customer can either pick up the items and have them destroyed or the 3PL can destroy them and give documentation to the customer.
Before you determine if your 3PL is capable of handling a real recall, it’s important to find out if the 3PL can handle fake recalls. “Mock recalls” are an important part of food and pharmaceutical warehouse management provided by your 3PL. These mock recalls serve as “practice runs” for actual recall events. They should be conducted as meticulously and thoroughly as the real thing.
Typically, a mock recall proceeds as follows.
- Details of the event are coordinated by the customer and 3PL, including product recall information and other key information (e.g. lot numbers).
- Items are flagged by the warehouse management system (WMS) which assigns the products a segregated hold location and prevents them from being distributed. The WMS can identify which lots of the recalled products were shipped and where they were shipped.
- Warehouse staff is notified, and each associate follows specific protocols.
- Recalled items are removed from the main warehouse floor and placed at the segregated holding location.
- As products enter the warehouse, the WMS is updated. All warehouse staff is notified and signage is posted.
- The 3PL provider has been updated with the customer and awaits any further instructions (e.g. whether to hold or arrange for the destruction of items). Please click here.
- The process of a “real” recall will be the same as a mock recall. The real thing should run smoothly after systems and staff have gone through successful practice runs.
Five things to watch out for in the 3PL pharmaceutical supply chain
When you begin your search for a 3PL to handle key pharmaceutical supply chain responsibilities such as warehousing, the following five questions are a great place to start.
Can the 3PL properly segregate products? There are many pharmaceutical products that have special segregation requirements. One example is that a product may need to be kept away from food, other pharmaceutical products, and items that have strong odors, such as tires or coffee. These requirements should be met by your 3PL. It is not enough to segregate products. Your 3PL must also commit to taking extra steps to avoid cross-contact as described above.
Can the 3PL warehouse accommodate your product’s climate requirements? The storage conditions for pharmaceutical products may dictate that they be kept at a certain temperature or humidity level. It is important to ensure that your 3PL meets these requirements and has safeguards in case the temperature or humidity falls outside of this range.
Is it possible to audit your 3PL providerNearly every 3PL that stocks pharmaceutical products will welcome regular audits from the product owners, whether they are announced or not? These audits may include an inspection of storage conditions, product placements, potential hazards, facility cleanliness records, training protocols, and other factors.
Also, the FDA might periodically inspect warehouses that stock pharmaceutical products. The best 3PLs are in constant audit readiness and always ready for an FDA or other auditing agency to visit.
Your 3PL can you flex space? Many companies are rethinking their inventory management strategies in the wake of COVID-19, which caused supply chain disruptions. Some companies may need to have more products in stock at their distribution centers. You will need to ensure that your 3PL is able to handle fluctuations in inventory volumes, whether they are up or down. You can also adjust your costs to meet your service and space requirements.
Is your 3PL ISO-certified? It is essential that your 3PL follows strict protocols when managing parts of the pharmaceutical supply chain. You can’t get more organized than thatISO-9001 certified. ISO-certified companies adhere to strict international standards in order to maintain quality and consistency.
There are many ISO-9001 standards that govern product recalls. These include standards to identify and control non-conforming outputs (products that have been damaged, expired or are otherwise not in compliance with requirements). Companies must demonstrate compliance with all standards in order to be ISO certified.
- Cleanliness and adequate storage space should be provided for 3PL warehouses. This will allow for inspection and maintenance. The warehouse facility should be well lit, ventilated, and provide the right environment for drug storage. A quarantine area should be provided for expired drugs or drugs that are not able to be used.
- Security systems and processes must be capable of preventing unauthorized entry to the facility and protecting against theft.
- According to FDA, drugs that do not have specific storage requirements should be kept at “controlled temperature”
- Provider inventory and WMS systems should be able to provide visibility into product locations.
- The 3PL must have the ability to document policies and procedures, inventories, and distribution.
- Kanban Logistics is the right choice for your pharmaceutical supply chain needs
Kanban Logistics is a North Carolina 3PL that has been ISO-certified and can perform recalls for your company. Kanban Logistics is a North Carolina 3PL that has over 1 million square feet of warehouse space, located between Boston and Miami. We adhere to the highest standards of quality and compliance to manage the space for our customers. This allows us to be a trusted partner for pharmaceutical companies in the region. To learn more about our services, contact Kanban today.